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510(k) Data Aggregation

    K Number
    K092684
    Device Name
    LAPAROSCOPIC RETRACTORS
    Manufacturer
    CARDINAL HEALTH, INC.
    Date Cleared
    2010-01-22

    (143 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K933008,K930667
    Why did this record match?
    Device Name :

    LAPAROSCOPIC RETRACTORS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Laparoscopic Retractors are designed to retract or elevate organs and tissues to provide better visualization access to surgical sites during minimally invasive laparoscopic procedures.

    Device Description

    The proposed Laparoscopic retractors are inserted through the trocar cannula and into the abdomen in order to provide visualization during laparoscopic surgery by retracting and manipulating organs at the surgical site.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for Laparoscopic Retractors by Cardinal Health. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study with detailed metrics typically associated with AI/software devices.

    Therefore, many of the requested categories are not applicable to the information provided. The document primarily details the regulatory process and asserts equivalence based on design, materials, and functional characteristics.

    Here's an analysis based on the provided text, indicating where information is not available or not applicable:

    1. A table of acceptance criteria and the reported device performance

    Acceptance CriteriaReported Device Performance
    Biocompatibility: Materials used in device must be acceptable for intended use as per ISO 10993 Part-1 "Biological Evaluation of Medical Devices"."All materials used in the fabrication of the Laparoscopic Retractors were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 'Biological Evaluation of Medical Devices'. These materials also were evaluated in accordance with industry recognized test methods and were found to be acceptable for the intended use."
    Functional Equivalence: Device performance must demonstrate substantial equivalence to currently marketed predicate devices with regard to functional characteristics."Performance testing demonstrated that the proposed device is substantially equivalent to the currently marketed predicate devices with regard to functional characteristics."
    Design and Material Equivalence: Device must be composed of the same or similar design, materials, and manufacturing characteristics as predicate devices."The proposed device and the predicate devices are composed of the same or similar design, materials and manufacturing characteristics."

    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    • Not Applicable. The document describes non-clinical performance testing and biological qualification tests, not a clinical test set with patient data. No sample size for a "test set" of patient data is mentioned.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    • Not Applicable. As no clinical "test set" involving expert review is described, this information is not relevant. The "ground truth" here relates to material safety and functional equivalence, established through scientific standards (ISO 10993) and engineering performance testing. The qualifications of the personnel conducting these non-clinical tests are not detailed.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    • Not Applicable. No adjudication method is mentioned as there is no clinical test set requiring expert consensus.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    • Not Applicable. This is a physical medical device (laparoscopic retractors), not an AI-assisted diagnostic or therapeutic device. No human readers or AI assistance are involved in its primary function or testing as described.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    • Not Applicable. This is a physical medical device. There is no algorithm.

    7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

    • The "ground truth" or basis for evaluation for this device is established through:
      • Scientific Standards: Adherence to ISO 10993 Part-1 for biocompatibility.
      • Engineering Performance Testing: Evaluation against industry-recognized test methods to compare functional characteristics with predicate devices.
      • Material Characterization: Comparison of materials and manufacturing characteristics to predicate devices.

    8. The sample size for the training set

    • Not Applicable. No training set is mentioned as this is not an AI/machine learning device.

    9. How the ground truth for the training set was established

    • Not Applicable. No training set is mentioned.
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